Clinical Study Number | 1230.18 |
---|---|
Study Indication | Ovarian Neoplasms |
Product | Volasertib |
Generic Name | Volasertib |
Lab Code | BI 6727 |
Clinical Phase | II |
Study Title |
Phase II randomized trial of the Polo-like kinase 1 inhibitor BI 6727 monotherapy versus investigator’s choice chemotherapy in ovarian cancer patients resistant or refractory to platinum-based cytotoxic therapy |
Study Document | Trial synopsis 1230.18_DR english |
Clinical Study Number | 1230.5 |
---|---|
Study Indication | Carcinoma, Non-Small-Cell Lung |
Product | Volasertib |
Generic Name | Volasertib |
Lab Code | BI 6727 |
Clinical Phase | II |
Study Title |
A randomized open-label Phase II trial of BI 6727 monotherapy and BI 6727 in combination with standard dose pemetrexed compared to pemetrexed monotherapy in second line non-small cell lung cancer |
Study Document | Trial synopsis 1230.5_DR english |
Clinical Study Number | 1230.30 |
---|---|
Study Indication | Leukemia, Myeloid, Acute |
Product | Volasertib |
Generic Name | Volasertib |
Lab Code | BI 6727 |
Clinical Phase | I |
Study Title |
An open label, Phase I, dose escalation trial to investigate the maximum tolerated dose, safety, pharmacokinetics, and efficacy of volasertib in combination with decitabine in patients >= 65 years with acute myeloid leukemia |
Study Document | Trial statement 1230.30 english Trial synopsis 1230.30 english Lay summary 1230.30 english |
Clinical Study Number | 1230.43 |
---|---|
Study Indication | Myelodysplastic Syndromes |
Product | Volasertib |
Generic Name | Volasertib |
Lab Code | BI 6727 |
Clinical Phase | I |
Study Title |
An open label, phase I trial of intravenous administration of volasertib as monotherapy and in combination with azacitidine in patients with myelodysplastic syndrome after hypomethylating agents treatment failure |
Study Document | Trial statement 1230.43 english Trial synopsis 1230.43 english |
Clinical Study Number | 1230.33 |
---|---|
Study Indication | Myelodysplastic Syndromes |
Product | Volasertib |
Generic Name | Volasertib |
Lab Code | BI 6727 |
Clinical Phase | I |
Study Title |
An open label Phase I dose escalation trial to investigate the maximum tolerated dose, safety, pharmacokinetics and efficacy of intravenous volasertib in combination with subcutaneous azacitidine in patients with previously untreated high-risk myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) and not candidates for hematopoietic stem cell transplant |
Study Document | Trial statement 1230.33 english Trial synopsis 1230.33 english |
Clinical Study Number | 1230.15 |
---|---|
Study Indication | Neoplasms |
Product | Volasertib |
Generic Name | Volasertib |
Lab Code | BI 6727 |
Clinical Phase | I |
Study Title |
An open-label phase I study of once every three weeks intravenous treatment with BI 6727 in Japanese patients with advanced solid tumours |
Study Document | Trial synopsis 1230.15 english |
Clinical Study Number | 1230.16 |
---|---|
Study Indication | Neoplasms |
Product | Volasertib |
Generic Name | Volasertib |
Lab Code | BI 6727 |
Clinical Phase | I |
Study Title |
A Phase I single dose escalation study of two dosing schedules of BI 6727 administered intravenously in Asian patients with various solid cancers with repeated administration in patients with clinical benefit |
Study Document | Trial synopsis 1230.16 english |
Clinical Study Number | 1230.2 |
---|---|
Study Indication | Urologic Neoplasms |
Product | Volasertib |
Generic Name | Volasertib |
Lab Code | BI 6727 |
Clinical Phase | II |
Study Title |
An open-label, single-arm, Phase II trial of intravenous volasertib (BI 6727) in patients with locally advanced, metastatic or recurrent urothelial cancer of the bladder, renal pelvis, or ureters after failure of prior chemotherapy |
Study Document | Trial synopsis 1230.2 english |
Clinical Study Number | 1230.20 |
---|---|
Study Indication | Neoplasms |
Product | Volasertib |
Generic Name | Volasertib |
Lab Code | BI 6727 |
Clinical Phase | I |
Study Title |
An open label phase I dose escalation trial of intravenous BI 6727 in combination with oral BIBW 2992 in patients with advanced solid tumours with repeated administration in patients with clinical benefit |
Study Document | Trial synopsis 1230.20 english |
Clinical Study Number | 1230.23 |
---|---|
Study Indication | Neoplasms |
Product | Volasertib |
Generic Name | Volasertib |
Lab Code | BI 6727 |
Clinical Phase | I |
Study Title |
Investigation of the metabolism, excretion and pharmacokinetics of an open-label single dose 300 mg (14C)volasertib administered intravenously in patients with various solid tumours with a possible extension phase with non-labelled drug |
Study Document | Trial synopsis 1230.23 english |
Clinical Study Number | 1230.26 |
---|---|
Study Indication | Leukemia, Myeloid, Acute |
Product | Volasertib |
Generic Name | Volasertib |
Lab Code | BI 6727 |
Clinical Phase | I |
Study Title |
An open label, phase I trial of intravenous once every 2 weeks administration of BI 6727 in Japanese patients with acute myeloid leukemia |
Study Document | Trial synopsis 1230.26 english |
Clinical Study Number | 1230.35 |
---|---|
Study Indication | Leukemia, Myelomonocytic, Chronic |
Product | Volasertib |
Generic Name | Volasertib |
Lab Code | BI 6727 |
Clinical Phase | I |
Study Title |
An open label Phase I trial of intravenous volasertib in combination with subcutaneous azacitidine in Japanese patients with higher-risk myelodysplastic syndrome or chronic myelomonocytic leukemia |
Study Document | Trial synopsis 1230.35 english |
Clinical Study Number | 1230.6 |
---|---|
Study Indication | Neoplasms |
Product | Volasertib |
Generic Name | Volasertib |
Lab Code | BI 6727 |
Clinical Phase | I |
Study Title |
A phase I dose escalation trial of BI 6727 in combination with cisplatin or carboplatin in patients with advanced or metastatic solid tumours |
Study Document | Trial synopsis 1230.6 english |
Clinical Study Number | 1230.7 |
---|---|
Study Indication | Neoplasms |
Product | Volasertib |
Generic Name | Volasertib |
Lab Code | BI 6727 |
Clinical Phase | I |
Study Title |
An open label phase I dose escalation trial of intravenous BI 6727 in combination with oral BIBF 1120 in patients with advanced solid tumours with repeated administration in patients with clinical benefit |
Study Document | Trial synopsis 1230.7 english |
Clinical Study Number | 1230.27 |
---|---|
Study Indication | Neoplasms ; Leukemia |
Product | Volasertib |
Generic Name | Volasertib |
Lab Code | BI 6727 |
Clinical Phase | I |
Study Title |
Open, non-controlled, dose-escalating Phase I trial to evaluate the pharmacokinetics, pharmacodynamics, tolerability, and toxicity of volasertib in paediatric patients from 2 years to less than 18 years of age with acute leukaemia or advanced solid tumour, for whom no effective treatment is known |
Study Document | Trial synopsis 1230.27 english Lay summary 1230.27 english |
Clinical Study Number | 1230.25 |
---|---|
Study Indication | Leukemia, Myeloid, Acute |
Product | Volasertib |
Generic Name | Volasertib |
Lab Code | BI 6727 |
Clinical Phase | II/III |
Study Title |
A phase II/III randomized, open-label study to compare the efficacy and safety of intravenous volasertib in combination with subcutaneous cytarabine versus investigator’s choice of anti-leukemic treatment in adult patients with relapsed or refractory acute myeloid leukemia with no established treatment options (POLO-AML 1) |
Study Document | Trial statement 1230.25 english |
Clinical Study Number | 1230.28 |
---|---|
Study Indication | Leukemia, Myeloid, Acute |
Product | Volasertib |
Generic Name | Volasertib |
Lab Code | BI 6727 |
Clinical Phase | I |
Study Title |
Open-label, dose-escalating trial to evaluate the tolerability, toxicity, safety, pharmacokinetics, pharmacodynamics and activity of volasertib added to the standard intensive salvage chemotherapy regimen with liposomal daunorubicine, fludarabine and cytarabine (DNX-FLA) followed by fludarabine and cytarabine (FLA) in children from 3 months to less than 18 years of age with acute myeloid leukaemia after failure of the front-line therapy |
Study Document | Trial statement 1230.28 english |
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